Study Compares DCB and Plain Balloon Angioplasty to Treat Femoropopliteal Artery Disease

August 16, 2016—Daniele Giacoppo, MD, et al published findings from an updated systematic review and meta-analysis of randomized clinical trials of drug-coated balloons (DCBs) versus plain balloon (PB) angioplasty for the treatment of femoropopliteal artery disease by in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2016;9:1731–1742).

The study sought to assess the risk of target lesion revascularization (TLR) and all-cause death at 12 months and at the maximum available follow-up. Secondary objectives included the identification of factors that could have influenced general findings.

As summarized in JACC: Cardiovascular Interventions, the investigators searched main electronic databases for randomized trials comparing DCB and PB angioplasty for femoropopliteal artery disease. Random effects models were used to estimate the risk of TLR and all-cause death at 12 months. Long-term TLR and death risk were assessed by mixed-effects Poisson regression models and incident rates of each outcome per patient-year. Main analyses were supplemented by sensitivity analyses, Bayesian estimates, and trial sequential analysis.

In a total of eligible trials, the investigators found that DCB use was associated with a marked 12-month TLR risk reduction compared with PB angioplasty (risk ratio, 0.33; 95% confidence interval [CI], 0.19–0.57). The risk of death was similar between groups (risk ratio, 0.96; 95% CI, 0.47–1.95). A long-term outcomes assessment showed a reduced incidence of TLR with DCB use (0.35; 95% CI, 0.24–0.51) and a similar incidence of all-cause death (incidence rate ratio, 1.13; 95% CI, 0.6–2.15). Similar findings were observed in Bayesian analyses.

Significant heterogeneity was present, with evidence of differential efficacy across devices. A trial sequential analysis indicated that the available evidence is sufficient to prove the superior antirestenotic efficacy of DCB over PB angioplasty.

The investigators concluded that DCB angioplasty significantly reduces the risk of TLR as compared with PB angioplasty, without any effect on all-cause death, and that evidence exists for differential efficacy according to the type of device used. Future trials investigating DCB angioplasty should include potentially more effective comparator therapies, advised the investigators in JACC: Cardiovascular Interventions.